Theobromine-based drug close to commercialization, has potential to address the serious need for a safer, opioid-free treatment for persistent cough
MAGNOLIA, Texas--(BUSINESS WIRE)-- Pernix Therapeutics Holdings, Inc. (NYSE Amex: PTX) (“Pernix”), an integrated specialty pharmaceutical company focused primarily on the pediatric market, today announced the establishment of a new joint venture with SEEK, a leading United Kingdom private drug-discovery group. The joint venture will undertake the late-stage development and registration of BC1036, a first-in-class antitussive drug designed to address the serious need for a safer and more effective, non-opioid treatment for persistent cough. Both parties also licensed or assigned all of their theobromine intellectual property to the joint venture.
Following consultation with a European regulatory authority, the new venture will conduct a single pivotal Phase III trial of BC1036, which is expected to begin in the first half of 2011. This truncated regulatory path is due to the significant historical safety data available for theobromine and the beneficial effect seen in human use to date. The new venture is also in discussions with the United States Food and Drug Administration and expects to confirm early next year the regulatory program.
Theobromine is a well known, safe product that is found in existing medicines and significant quantities of cocoa-based products including chocolate and as a metabolite of caffeine. Based on a review of available data, Pernix believes theobromine has been shown to inhibit the inappropriate firing of the vagus nerve which is a key feature of persistent cough. This peripheral mechanism of action differentiates theobromine from codeine and other centrally acting agents, which Pernix believes leads to its lower central nervous system side effect.
Persistent cough is a very common condition, affecting an estimated 10-12.5%1 of people globally. In persistent cough, symptoms persist for more than two weeks and may arise mainly from cough predominant asthma, oesophageal reflux and rhinitis. The cough market has seen little to no innovation over the past twenty years despite the side-effects associated with current treatments. The Commission on Human Medicines and its Paediatric Medicines Expert Advisory Group advised that codeine, a drug used in most common cough treatments, should be withdrawn from use by children under the age of 18 in the OTC market in the United Kingdom.
Based on the successful launch of BC1036 in 2009 as AnyCough™ in Korea and the resulting substantial data package, BC1036 has the potential to be on the market in Europe and the U.S. within two years from trial commencement, subject to receiving marketing authorization. The new venture is collaborating closely with leading experts in the U.K. -- Professor Morice, Head of Hull Cough Clinic, and Professor Ian Pavord, University Hospitals Leicester.
Professor Alyn Morice, Head of the Hull Cough Clinic, commented: “Thousands of people across the U.K. suffer from persistent cough and, due to the drawbacks of current opioid drugs such as codeine, we are in desperate need of a non-opioid treatment with a drastically improved side effect profile for patients.”
Professor Ian Pavord, Department of Respiratory Medicine and Thoracic Surgery, Glenfield Hospital, Leicester, commented: “Persistent cough is a highly debilitating condition that severely impacts the lives of sufferers and their family and friends. Currently available treatment options are limited and often associated with negative side effects. The existing human data on BC1036 is very exciting and I look forward to being in a position to offer an effective and safe drug to our patients.”
Manfred Scheske, who has recently joined SEEK as CEO of Consumer Health, will provide leadership to the development of BC1036. Mr. Scheske was formerly President of Consumer Healthcare Europe at GlaxoSmithKline (“GSK”), where he enjoyed a highly successful 25-year career with GSK in Europe, North America and at a global level within GSK’s Consumer Healthcare Leadership Team.
Commenting on this announcement, Manfred Scheske, CEO of Consumer Health at SEEK, said: “I am very excited that we have funding for the late-stage development of BC1036, which has the potential to dramatically impact the treatment of persistent cough and could greatly benefit the quality of life of persistent cough sufferers. Utilizing my extensive U.S. and European experience from GSK, I am very much looking forward to taking this program forward towards commercialization and to announcing the commencement of our Phase III trial next year.”
Cooper Collins, President and CEO of Pernix, said: “This partnership is an exciting step forward in the growth of our company and provides an opportunity to increase our share of the approximately $3 billion global market for prescription and OTC cough suppressants. By partnering with SEEK, we are able to advance this novel codeine-free natural cough suppressant in a more cost-effective and lower risk regulatory path. Given the lack of new treatments for persistent cough over the last two decades, we believe that our non-opiate antitussive medicine offers an innovative alternative treatment for persistent cough sufferers and look forward to working with SEEK to advance the development of BC1036 through commercialization in Europe and the U.S.”
About Pernix Therapeutics
Pernix Therapeutics Holdings, Inc. is an integrated specialty pharmaceutical company primarily focused on serving the needs of the pediatric marketplace. Commercially-proven branded product families include CEDAX®, Brovex®, Aldex®, Pediatex®, ReZyst®, QuinZyme® and Z-Cof®. The Company was originally founded in 1999 and is based in the Houston, TX metropolitan area. Additional information about Pernix is available on the Company’s website located at www.pernixtx.com.
Cautionary Notice Regarding Forward-Looking Statements
The Company wishes to caution readers not to place undue reliance on any forward-looking statements, which speak only as of the date made. No assurances can be given regarding the future performance of the Company. The Company wishes to advise readers that factors could affect the Company’s financial performance and could cause the Company’s actual results for future periods to differ materially from any opinions or statements expressed with respect to future periods in any current statements.
The Company does not undertake, and specifically declines any obligation, to publicly release the result of any revisions which may be made to any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.
1. Department of Cardiovascular and Respiratory Studies, University of Hull, Castle Hill Hospital, Cottingham, East Yorkshire, UK, [email protected]
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Pernix Therapeutics Holdings, Inc.
Tracy Clifford, 843-720-1501
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